Pharmacovigilance in Germany and Europe
Why Germany records adverse drug reaction reports
In the past, adverse drug reactions in Germany were often collected in a decentralized manner. This means that various players in the healthcare system, i.e. patients, medical professionals and authorities, reported side effects in a wide variety of ways. Today, the trend is moving in a different direction – reporting is increasingly centralized and Europe-wide, which is significantly more efficient.
For this reason, the German Pharmaceutical Industry Association (BPI) predicted in 2016 that the number of reportable adverse drug reactions would increase to 500,000 per year. In this context, reports from all parties are collected and processed centrally by the European Medicines Agency (EMA).
In fact, the recording and monitoring of side effects still makes an essential contribution to drug safety even after marketing authorization. Some, very rare side effects, for example, only come to light through monitoring of the broad masses. In addition, a more efficient and accurate benefit-risk analysis can be carried out in this way.
What is the legal basis for the monitoring of medical products?
In Germany, pharmaceutical manufacturers with approved drugs are required by Section 63b of the German Medicines Act (AMG) to set up a pharmacovigilance system, i.e. a system for the systematic monitoring of their drugs.
Physicians and pharmacists are also required to report adverse drug reactions to the respective drug commission when they become aware of them. Patients can also submit drug reports, but are not required to do so, even in the case of unexpected serious side effects.
Patients are the most powerful source of information and are actually best suited to fill the pharmacovigilance systems of pharmaceutical manufacturers with valuable data.
What ways are there to report adverse drug reactions?
Fig. 1 Current reporting system in Europe
A look at the existing reporting system in Germany shows the variety of possibilities that can be very confusing for patients and reporters: Physicians and pharmacists are supposed to report ADRs to their respective drug commissions. For physicians, the Drug Commission of the German Medical Association (Arzneimittelkommission der Deutschen Ärzteschaft, short AkdÄ) is responsible; for pharmacists, the Drug Commission of German Pharmacists (Arzneimittelkommission der Deutschen Apotheker, AMK) is responsible.
These two drug commissions then collectively forward the reports to the higher federal authorities, i.e. the Paul-Ehrlich-Institut, PEI for short, and the Federal Institute for Drugs and Medical Devices, BfArM for short. From there, complete reports are forwarded to the EMA’s European pharmacovigilance system, called EudraVigilance.
However, it has become established that physicians and pharmacists report side effects directly to the pharmaceutical manufacturers from time to time. This is because reports are often accompanied by medical questions or product complaints.
In addition to these reports, pharmaceutical manufacturers also receive reports from patients themselves and forward them to the EMA via their pharmacovigilance system. There, the reports are in turn entered into EudraVigilance.
As you can see in the diagram, patients can report to all institutions themselves, i.e. to pharmaceutical manufacturers, to physicians and pharmacists, and to the higher federal authorities. With these diverse reporting chains, which are often confusing for the user, it is not difficult to assume that duplicate reports or even the disappearance of individual reports can occur.
In addition, the submission of a report is not necessarily clearly structured for the average citizen. For a report to be considered complete, it must fully meet four criteria:
- One or more suspected side effect(s).
- One or more suspect substance(s) or medical product(s).
- One or more uniquely identifiable patient(s).
- One or more clearly identifiable reporting source(s).
Why XO Life collects patient data on adverse events
While digitalization in the healthcare sector increasingly demands multilateral communication at eye level, comprehensive access to health information, as well as trust and security, we have made it our mission to support this development.
To this end, we have established a multidirectional communication platform that patients can use to report adverse drug reactions quickly, easily and in a structured manner. The reports are passed on to the respective marketing authorization holder pseudonymously, i.e. without revealing the personal identity of the reporter. Manufacturers, for their part, can send digital follow-up questions to patients with just a few clicks, which they can answer directly on their smartphones or laptops.
What are the benefits of XO Life’s platform?
Our platform has been shown to result in a 10-fold increase in the rate of patient feedback. Total reports can usually be closed after 72 hours, which is a significant time improvement to the current system. A look at the current number of drug reports shows that of slightly over 60.000 reports received in 2020, nearly 30% were processed through XO Life’s platform. However, the number of total drug reports has been declining; for example, in 2018, there were still approximately 80.000 reports. This is certainly due to declining physician visits in the COVID-19 pandemic. Medical professionals recorded about 15% fewer reports during this period.
However, it is interesting to note that direct patient reports increased by 36% during the same period.[4;5] This clearly underlines the trend of so-called patient empowerment. Patients are increasingly taking their health concerns into their own hands. To this end, patients are using digital, user-centric tools for direct communication between patients and pharmaceutical manufacturers. XO Life’s communications platform is a typical example of such a digital tool.
This is how we would like to shape the pharmacovigilance of the future, through digitization and automation.
It is our goal to make clearly structured data sets accessible to enable pharmaceutical manufacturers to evaluate safety-critical data both quickly and efficiently. Of course, it is our highest aspiration to perform this work in compliance with all rules of the DSGVO.
Almost 100 pharmaceutical manufacturers are already registered on XO Life’s real-world evidence platform. 50% of these also use the digital enquiry option for patients – and the trend is rising sharply. This clearly shows that pharmaceutical manufacturers are very interested in a simple reporting and communication platform to get in touch with their customers.
This not only helps general drug safety, but also makes work easier for the pharmacovigilance departments of many pharmaceutical manufacturers. XO Life helps patients and pharmaceutical companies to get in direct contact to create an all-encompassing reporting and communication platform with real-world care data.
 Bundesverband der Pharmazeutischen Industrie e. V. & Thurisch, B. (2016). Erfassung von Nebenwirkungsberichten Herausforderungen für die pharmazeutische Industrie [Vorlesungsfolien]. Bfarm.de. https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Termine-und-Veranstaltungen/dialogveranstaltungen/dialog_2016/160226/03_Folien_Thurisch.pdf?__blob=publicationFile&v=2
 Kommas, E., Lex, D., Huber, M. & Paeschke, N. (2019). Verdachtsfälle melden. DAZ.online. https://www.deutsche-apotheker-zeitung.de/daz-az/2019/daz-37-2019/verdachtsfaelle-melden
 European Medicines Agency. (2017). Guideline on good pharmacovigilance practices (GVP). ema.europa.eu. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf Zuletzt aufgerufen: 19.05.2021
 Bundesinstitut für Arzneimittel und Medizinprodukte. (2021). Nebenwirkungsmeldungen Sachstand BfArM. 88. Routinesitzung.
 Bundesinstitut für Arzneimittel und Medizinprodukte. (2019). Nebenwirkungsmeldungen Sachstand BfArM. 84. Routinesitzung.